Atlas

FDA-Inspected Site

Alexion Pharma International Operations Limited

3 FDA inspections are on record for Alexion Pharma International Operations Limited in Dublin 15, Ireland.

483· Form 483 issued

Dublin 15, Ireland · Last updated August 15, 2026

Overview

  • 3 FDA inspections are on record.
  • 1 inspection produced a Form 483.
  • The most recent recorded inspection date is 2023-01-24.

At a glance

Inspections

3

Form 483s

1

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
16 Jan 2023 – 24 Jan 2023Human Drugs483On file
30 Apr 2018 – 2 May 2018Human DrugsClean
2 Feb 2017 – 3 Feb 2017Human DrugsClean

Investigators

FDA investigators tied to this site in the record.

Zhong Li1 insp.
Jacek Cieslak1 insp.
William J Leonard1 insp.
Laura Fontan1 insp.

Full site report

Get the verbatim findings behind Alexion Pharma International Operations Limited's 1 Form 483

The full inspection record, as Atlas holds it, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat